Optimer shares fall on news of co-marketing deal for antibiotic

Optimer Pharmaceuticals' prescription antibiotic fidaxomicin, also known as Dificid, is aimed at treating a potentially deadly intestinal infection that is increasingly common in hospitals and nursing homes.
— John R. McCutchen

Optimer Pharmaceuticals' prescription antibiotic fidaxomicin, also known as Dificid, is aimed at treating a potentially deadly intestinal infection that is increasingly common in hospitals and nursing homes.
— John R. McCutchen

A day after a federal advisory panel endorsed Optimer Pharmaceuticals’ new antibiotic for approval, the San Diego company said Wednesday that it would co-market the drug with Cubist Pharmaceuticals, which already sells its own antibiotic in hundreds of hospitals across the country.

The deal represented a shift in plans for Optimer, which until Wednesday morning had said it would launch fidaxomicin pills on its own once the treatment for Clostridium difficile infection was approved by the Food and Drug Administration.

Shares of Optimer fell 81 cents, or 6 percent, Wednesday to $12.99. In premarket trading before the co-marketing deal was announced, the stock had risen 25 cents on news of Tuesday’s unanimous favorable vote by the FDA’s Anti-Infective Drugs Advisory Committee.

The drug, which will be sold under the brand name Dificid, still faces a final decision by the FDA, which is expected by May 30.

The agency rarely goes against the advice of its experts, and one stock analyst said Dificid had an 85 percent chance of being approved.

Under the co-marketing deal, Optimer will pay Cubist $30 million in service fees over the two-year life of the agreement. The Lexington, Mass., company will receive an additional $5 million in the first year and $12.5 million in the second year if certain sales milestones are achieved. Cubist also will share in profits from the drug above certain sales-target levels.

Cubist has been selling its own injected antibiotic, Cubicin, since November 2003 to hospitals for the treatment of skin infections including MRSA.

Since Dificid will be Optimer’s first drug to make it to market, the company is creating an in-house team of 100 sales representatives from scratch. The group will be based out of New Jersey, where the bulk of the nation’s pharmaceutical marketing activity is centered.

If the FDA approves Dificid by May 30, the drug could go on sale in the United States by early August, the company’s chief executive and president, Pedro Lichtinger, said in an early-morning conference call with stock analysts.

The Optimer representatives will focus on the 1,100 hospitals that generate the largest numbers of C. difficile patients, Lichtinger said.

The Cubist deal will put Dificid in an additional 1,000 hospitals, he said.

“This will be the most intense launch in hospitals in the history of the United States,” Lichtinger said. “We believe together we will achieve a much higher revenue than what Optimer would have achieved by itself.”

The short-term nature of the agreement will let Optimer take over all sales responsibilities within two years, he said.

That could be important, because Cubist is developing its own treatment for C. difficile that eventually could compete against Dificid. That drug is in Phase 2 clinical trials and is at least four years away from FDA review, Lichtinger said.

The bacterial infection is among a group of hard-to-fight illnesses known as “super bugs” that have infiltrated hospitals over the past decade, annually infecting more than 2 million Americans, killing 99,000 patients and costing more than $4.5 billion in extra care.

C. difficile infects about 500,000 people each year in the United States and kills nearly 30,000, according to the Centers for Disease Control and Prevention.

Only one drug has been approved by the FDA to treat the illness, but about 30 percent of patients who take the medication suffer a relapse.

In clinical trials, about 12 percent of people taking Dificid redeveloped the infection within 30 days of completing treatment.